Clinical Study on Deep Pressure Therapy

Transcription

1 Clinical Study on Deep Pressure Therapy The Snug Vest s Effects on Anxiety and Behaviour in Children with Autism Spectrum Disorder* Study by: Sponsored by: Kayla D. Ten Eycke & Dr. Ulrich Müller Psychology Department Abstract of Background Deep Pressure Therapy devices are widely used in the treatment of autism, yet little scientific evidence exists to support their effectiveness. Purpose We tested the effects of an inflatable garment that applies pressure to the torso (the Snug Vest ). Method We conducted an ABAB withdrawal design to test the effects of the vest in 7 children (5-9 years-old) with Autism Spectrum Disorder. We compared treatment ( on-days, wearing the vest inflated vs. off-days, wearing the vest deflated or not at all), and intervention time point (prior to, directly following, and after a delay). Findings We found a significant interaction between treatment and time point for parents subjective ratings of attention and for salivary cortisol levels, and a significant effect of the vest on naïve coders ratings of problem behaviors. We found no effect on blood pressure or heart rate. Implications These findings suggest that the garment can have beneficial effects on the functioning of some children with autism. *Note: this study is pending publication

2 Purpose The purpose of this research is to test the effects of the Snug Vest, an inflatable garment, that applies pressure to the torso on behavioural and physiological function using ABAB method. Method The study involved an withdrawal design} ABAB to test the effects of the vest on 7 children with Autism Spectrum Disorder PDD-NOS AS PDD-NOS : Autism Spectrum Disorder AS: Asperger Syndrome PDD-NOS: Pervasive Developmental Disorder, Not Otherwise Specified The study compares treatment on: ON 5-9 years old DAYS {wearing the vest inflated} OFF and intervention time points. DAYS {wearing the vest deflated or not at all} Day 1 Day 2 Day 3 Day 4 Day 5 No vest Inflated vest Deflated vest Inflated vest No vest Measures 1 Parent questionnaires: 2 Physiological measures: 3 Behavioural observation: 1 Pre-session questionnaire Pre-experiment questionnaire Sensory profile Vineland adaptive behaviours scale Post-session phone questionnaire Intervention Session a. Salivary cortisol Measured beginning of, end of, & 20 mins. following, each intervention period. the 20 minute comprised of 3 activities: Computer game Designed to challenge sustained attention (Continuous Performance Task). 2 Card sorting game 3 Zelazo, b. Blood pressure c. Heart rate Measured beginning Continuous recording of, end of, & 20 during intervention mins. following, each period. intervention period. Jigsaw puzzle Participants were video recorded during the intervention period. Two naive coders per child identified and coded a range of problem behaviours. Data Analysis All data was entered into IBM SPSS statistics software, V.21 for analysis. Because many participants demonstrated elevated anxiety and behaviour problems on the first day, Day 1 data is excluded from analysis. Data analyzed using 2 x 3 repeated measures analysis of variance (ANOVA) with treatment (on-days, off-days) and time points.

3 Results 1 Parent questionnaire Mean parent rating of child s attention: Parents indicated that their children were more attentive on on days (day 2&4) and less attentive on off days (day 3&5). Attention rating on a 7-point Likert scale. very attentive very low attention Directly prior to intervention Directly following 20 mins. following We found a significant interaction between treatment and time point, such that parents indicated that their children were more attentive directly after and two hours following the on days when their children wore the vest inflated, but less attentive on days when their child wore the vest deflated or not at all. Kayla D. Ten Eycke 2 Physiological measures a. Mean Participant Salivary Cortisol Levels: Salivary cortisol levels (in nanograms per milliliter) decreased during and decreased post intervention, regardless of on & off days. There was a significant interaction between time point and treatment condition. Cortisol is a major glucocorticoid, produced in the adrenal cortex, which rises in response to stress. Salivary cortisol levels (ng/ml) on-days: day 2 & 4 off-days: day 3 & 5 Salivary cortisol levels (ng/ml) Directly prior to intervention Directly following 20 mins. following Directly prior to intervention Directly following 20 mins. following b & c. Blood Pressure & Heart Rate: No significant differences found

4 3 Behavioural observation Naive Coders Ratings of Problem Behaviours: Two naïve raters scored the frequency of participants problem and off-task behaviors over the intervention session. Based on a paired samples t-test with treatment ( on & off days) as the independent variable, coders observed significantly more problem behaviors on off days (M = 5.4 SD = 3.1) compared to on days (M = 2.8 SD = 2.8), t(6) = 3.556, p = Frequency of participants problem and off-task behaviors Participant 1 Participant 2 Participant 3 Participant 4 Participant 5 Participant 6 Participant 7 Day 1 Day 2 Day 3 Day 4 Day 5 No vest Vest on and inflated Vest on but deflated Vest on and inflated No vest Discussion: Whereas the majority of previous studies have found no effect for deep pressure treatments, the present study provides tentative support for such treatment....to the best of our knowledge, this is the first study to use such a comprehensive set of assessments. Further research using extended treatment and more varied outcome measures is necessesary to corroborate the current findings and ascertain their generalizability to real-life contexts. Kayla D. Ten Eycke

5 Beta Trial Feedback Study on Usability, Efficacy, and Performance of Snug Vest for Children with a range of disorders Study by: Sponsored by: Approved by: Lisa Fraser & Lucia Hsieh (Product researchers / developers) Abstract Background Prior to commercialization of Snug Vest, we gathered feedback for better understanding of product use and to make final improvements on product. Purpose We gathered feedback on usability, efficacy, and performance of a Snug Vest - Deep Pressure vest. Method We conducted a 28-day study in a reallife context: home or school-based setting, to collect data from 15 children (6-9 years old) with a range of disorders. An initial phone call was made with each caretaker prior to starting the trial. The children were instructed to fill out worksheet booklets and caretakers of Research Ethics Board (parents, therapists, or teachers) filled in questionnaires for 4 weeks. On the 28th day, a phone interview was conducted for follow-up. Findings The results show that most children benefited from using the Snug Vest. No major product changes were needed prior to commercialization. Implications Feedback suggests that Snug Vest can be beneficial to reduce amount of time, and occurrences of symptoms experienced throughout the week. Due to small sample size, this beta study serves as a pilot for conducting larger clinical and efficacy testing in the future.

6 Purpose To analyze if the vest was working as intended, find out the frequency of use, and extract information for how to improve the product. We wanted to test the vest in real-time environments including home with parents, classrooms with teachers, and therapy center with occupational therapists. Method Each participant was given a beta kit to complete the study. The beta kit consisted of: A beta Snug Vest & pump Instructions manual and CD Warranty sheet Worksheet booklet Stationery kit (marker, coloured pencils, post-its). 28 Day Schedule Caretakers including parents, teachers, and therapists were asked to fill out weekly questionnaires and worksheets with their children, followed by a phone interview as outlined in the 28 day schedule. 15 children participated in this study with a range of disorders. See below: 15 8 } The beta trial asked the caretaker/ parent to fill out weekly questionnaires from Qualtrics. Children were asked to fill in worksheet booklets that gave us information on the efficacy and performance of Snug Vest. The booklet also included additional time logs, journals, and worksheets for reference. SPD ADHD F BIPOLAR ANXIETY 5-13 years old SPD ADHD DOWN SYNDROME SPD NOT SPECIFIED 8 caretaker fully completed all 4 weekly questionnaires. TS NOT SPECIFIED : Autism Spectrum Disorder SPD: Sensory Processing Disorder ADHD: Attention Deficit Hyperactivity Disorder F: Fetal Alcohol Syndrome Disorder TS: Tourette s Syndrome Child with Parent Child with Therapist Child with Teacher Week 1 A B Assurance call Call was made to ensure beta kit was delivered and to set official start date. Week 2 A B A Worksheet A Worksheet A is filled out prior to, during, and after inflating vest for maximum 20 mins. Week 3 Week 4 A B B A B Worksheet B Worksheet B is filled out during inflation session. Online questionnaire Follow-up phone interview

7 Measures 1 Usability 2 Efficacy 3 Pressure performance User Benefits We asked caretakers if user benefited from wearing Snug Vest on the fourth week. Most users benefited, while a small portion of caretakers required more time to determine whether they will benefit from Deep Pressure. Caretakers Questionnaire Questionnaire was taken to determine if each component of the vest and pump were satisfactory. a. Caretakers Questionnaire Caretakers filled in questionnaire to see if child s symptoms were better or worse each week. a. Caretakers Questionnaire Caretakers filled in questionnaire to determine how satisfied they were with pressure distribution of vest. 11% 22% 67% b. Worksheet A b. Worksheet B 1 Results Usability Children circled how they felt prior to, during, and after 20 minute inflation session. Children also used orange pencil to colour areas of physical comfort, and used green pencil to colour areas of discomfort. Child was shown a front and back view of child s silhouette, where it sectioned off shoulders, chest, stomach, and sides. Child was asked how much pressure they felt and if it was enough pressure while wearing Snug Vest. Yes No Can t tell yet Responses recorded from 9 participants Caretakers Questionnaire on 15 Snug Vest Features On average, 12 features were satisfactory and 4 features including deflation tube whistle noise, pump, hood drawstrings, and hood were not satisfactory. On the commercialized Snug Vest 2013 version, we replaced the beta pump with a higher quality pump with faster inflation rate. We also eliminated the hood drawstrings for safety purposes and are looking for detachable hood options and alternative deflation tubes that are less noisy while retaining current fast deflation rate. Very dissatisfied Somewhat dissatisfied Somewhat Satisfied Very Satisfied Dissatisfied Neutral Satisfied 1. Inflation tube location 2. Pump clipping mechanism 3. Deflation tube location 4. Deflation tube whistle noise 5. Deflation tube ease of use 6. Velcro shoulder adjustment 7. Velcro side adjustment 8. Use of Velcro 9. Pump 10. Hood 11. Height of collar 12. Hood drawstrings 13. Chin guard 14. Top shoulder strap 15. Pockets

8 2 Efficacy a. Parent Questionnaire Symptom s Occurrences Throughout The Week Based on parent s feedback, there were positive outcomes that show decrease in anxiety, tantrums, meltdowns, and tactile defensiveness occurrences throughout the weeks after starting the trial. There were neither positive nor negative results for imbalances and stimming. > 3 times a day 1-2 times a day 4-6 times a week Anxiety Tantrums Imbalances Meltdowns Stimming Tactile Defensiveness 1-3 times a week none Prior to trial Week 1 Week 2 Week 3 Week 4 Amount of Time Participant Experiences The Symptoms The data shows that the amount of time children experience tantrums, and panic attacks decreased; while there were no positive nor negative changes in meltdowns, stimming, or self-injuries min 5-10 min Panic attacks Tantrums Self-injuries Meltdowns Stimming 2-4 min 1-2 min < 1 min none Prior to trial Week 1 Week 2 Week 3 Week 4

9 b. Child s Emotions Prior to, During, and After Inflation Session (Worksheet A) On Worksheet A, children were asked to circle different emoticons that corresponded to how they felt at the moment. In total, children had more positive emotions after inflating vest. 25 Frequency of Child s Emotions Positive emotions Very happy, happy, comfortable/calm, excited, secure, relieved, focused. Neutral emotions Neutral, tired. Negative emotions Anxious, confused, angry, annoyed, bored, scatterbrained. Worksheet A Example 3 Directly prior to inflation session Pressure Performance During inflation session 20 mins. following inflation session a. Parent Questionnaire on 6 Deep Pressure Benefits On average, all 6 deep pressure benefits were satisfactory. Based on the questionnaires, participants were most satisfied with adjustable pressure levels. The least satisfying pressure benefit was pressure on shoulders. Very dissatisfied Dissatisfied Somewhat dissatisfied Neutral Somewhat Satisfied Very Satisfied Satisfied 1. Evenly distributed pressure 2. Adjustable pressure levels 3. Pressure on back 4. Pressure on shoulders 5. Pressure on sides 6. Minimal pressure on stomach and chest b. Pressure mapping (Worksheet B) Out of the 3 children that completed this exercise, on average, all 3 mentioned that pressure was just right throughout sides, stomach, chest, upper and lower back regions. On average, pressure was not enough on the shoulders. Shown on the right is an example of a child who filled out Worksheet B with their caretaker. Question 1 asked how much pressure the child felt and second question asked if pressure was enough.

10 Time Logs and Journals Caretakers filled out optional time logs and journals in the worksheet booklet to keep track of Snug Vest usage. In the timelogs and journals, caretakers expressed how Snug Vest has helped the child in different activities throughout the week. We had a lovely family meal at Pizza Hut. Theo coped brilliantly after wearing the vest. Even though the restaurant was busy, he managed 1.5 hours there. During therapy sessions, if he wore the vest, I found that he would be doing more directed tasks and interact more with me rather than wandering around the clinic. Day 27, Wiggs, Mother Day 28, Lang, OT Time Log Example Journal Example Discussion In general, we received mostly positive feedback on usability, efficacy and performance of Snug Vest. We are happy to see that children with a range of disorders are benefiting from wearing the vest, not just limited to autism spectrum disorders. For areas where we received less satisfactory feedback, we have already improved on aspects of Snug Vest including: pump, instruction manual, and clear labelling. We hope to improve pressure on shoulders in the future. Due to the limited sample size, we believe that this study serves as a pilot for conducting larger clinical and efficacy testing in the future. With every Snug Vest we make, we truly hope that the vest will benefit all users. Snug Vest Team, October 2014